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Daiichi Sankyo - AstraZeneca's Enhertu Receives Priority Review In US For Lung Cancer

Daiichi Sankyo - AstraZeneca's Enhertu Receives Priority Review In US For Lung Cancer

Daiichi Sankyo-阿斯利康的Enhertu在美國獲得肺癌優先審查
Benzinga Real-time News ·  2022/04/19 07:15
  • The FDA has accepted for review AstraZeneca plc (NASDAQ:AZN) - Daiichi Sankyo's (OTC:DSNKY) supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for non-small cell lung cancer (NSCLC) setting.
  • The application covers unresectable or metastatic NSCLC whose tumors have a HER2 (ERBB2) mutation and who have received prior systemic therapy. 
  • The application has also been granted Priority Review.
  • Related: AstraZeneca's Stock Gain After Enhertu Meets Primary Endpoint In HER2-Low Breast Cancer Setting.
  • The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is during the third quarter of 2022.
  • The sBLA is based on data from the registrational DESTINY-Lung01 Phase 2 trial.
  • Preliminary results demonstrated a confirmed objective response rate of 54.9% in patients treated with Enhertu (6.4mg/kg). One (1.1%) complete response and 49 (53.8%) partial responses were observed.
  • A confirmed disease control rate of 92.3% was seen, with a reduction in tumor size observed in most patients. 
  • The median duration of response for Enhertu was 9.3 months. The median progression-free survival was 8.2 months, and the median overall survival was 17.8 months.
  • Price Action: AZN shares are up 0.17% at $68.73 during the premarket session on the last check Tuesday.
  • FDA已接受審查阿斯利康(納斯達克：azn)-第一三共的(場外交易代碼：DSNKY)用於非小細胞肺癌(NSCLC)治療的Enhertu(曲妥珠單抗)的補充生物製品許可證申請(SBLA)。
  • 該應用涵蓋無法切除或轉移性非小細胞肺癌，其腫瘤具有HER2(ERBB2)突變，並曾接受過系統治療。
  • 該申請還獲得了優先審查。
  • 相關： 阿斯利康在Enhertu在HER2-低位乳腺癌環境中遇到主要終點後的股票收益.
  • 處方藥使用費法案(PDUFA)的日期，也就是FDA做出監管決定的行動日期，是在2022年第三季度。
  • SBLA基於註冊Destination-LUNG01第二階段試驗的數據。
  • 初步結果顯示，在接受Enhertu(6.4 mg/kg)治療的患者中，確認的客觀有效率為54.9%。完全緩解1例(1.1%)，部分緩解49例(53.8%)。
  • 確診的疾病控制率為92.3%，在大多數患者中觀察到腫瘤大小縮小。
  • Enhertu的中位緩解期為9.3個月。中位無進展生存期為8.2個月，中位總生存期為17.8個月。
  • 價格行動：在週二的盤前交易中，AZN股價上漲0.17%，至68.73美元。
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